SB 66 CO Passed One Chamber
Regulation of Compounded Weight-Loss Medication
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Summary
This bill establishes comprehensive regulations for the sale and distribution of compounded weight-loss medications in Colorado, which are custom-made drugs containing FDA-approved ingredients used for obesity or weight management. The bill requires compounded weight-loss medications to be manufactured from FDA-approved substances, produced in compliance with FDA processes, manufactured at FDA-registered facilities inspected within two years, and verified for purity and accurate dosage. Labels must list all ingredients and their country of origin, and must include a warning that the medication has not been FDA-approved and has inadequate evidence of safety or efficacy. The bill prohibits false or misleading advertising claims and requires sellers to maintain records for at least two years after medication expiration. The State Board of Pharmacy can impose fines of up to $1,000 per dose and revoke licenses for violations, and the Attorney General can enforce the bill as a deceptive trade practice under Colorado's Consumer Protection Act.
AI-generated plain-language summary of the bill (from the OpenStates abstract — no full text available yet) — neutral, and may be imperfect.
Official abstract
The bill establishes regulations for the sale, transfer, or distribution of compounded weight-loss medication, which custom-made medications that, is defined in the bill as a drug that is: Created by combining, mixing, or altering other drugs or drug substances; Intended to be used by humans for obesity or weight management and contains an active ingredient that is named in a drug approved by the federal food and drug administration (FDA); and A glucagon-like peptide-1 receptor agonist drug, known as a 'GLP-1' drug. Unlike mass-produced medications, a compound weight-loss medication is not subject to approval by the federal food and drug administration (FDA). A person may not sell, transfer, or distribute a compounded weight-loss medication unless the person confirms that the medication: FDA. Is made from bulk drug substances and drugs that are approved by the FDA when such approval is required; Was manufactured in compliance with FDA processes; Contains bulk drug substances that are pharmaceutical grade and are accompanied by a certificate of analysis containing information that is material to the safety and efficacy of the bulk drug substances; Was manufactured at a facility that is registered with the FDA and passed an FDA inspection within the previous 2 years; and Is verified for purity and accurate dosage. Labels for compounded weight-loss medications must list all active and inactive ingredients, the quantity of those ingredients, and the ingredients' country of origin. There must also be a warning on the label stating that the compounded weight-loss medication has not been FDA-approved, has inadequate evidence of safety or efficacy, and has known and unknown side effects. A person must also provide certain disclosures to a patient when prescribing compounded weight-loss medications. The bill prohibits the use of false or misleading claims, including unsubstantiated claims, when advertising or promoting compounded weight-loss medications. A person that sells, transfers, or distributes compounded weight-lost medication must keep records related to the compounded weight-loss medication for at least 2 years after the date of expiration of the compounded weight-loss medication and make those records available for inspection by the state board of pharmacy. The state board of pharmacy may issue fines of up to $1,000 per dose of compounded weight-loss medications that are sold or distributed in violation of the bill and may revoke a pharmacy or business license for violations. The attorney general has authority to enforce this bill as a deceptive trade practice under the 'Colorado Consumer Protection Act'. The bill establishes that a person engages in a deceptive trade practice when the person : Makes a false or misleading claim about a compounded weight-loss medication when advertising or promoting the medication; Distributes a compounded weight-loss medication when not legally authorized to distribute or transfer the drug used in the compounded weight-loss medication; Makes a materially false or misleading representation that the compounded weight-loss medication is approved by the FDA when the medication is not approved by the FDA; or Makes a materially false, misleading, or unverified claim regarding the efficacy, safety, performance, outcomes, or benefits of the compounded weight-loss medication. The attorney general has exclusive authority to enforce the bill as a deceptive trade practice under the 'Colorado Consumer Protection Act'. There is no private right of action for a violation of the bill, and the provisions of the bill may only be enforced by the attorney general. The bill does not apply to certain facilities or in certain circumstances, including: The administration of a compounded weight-loss medication by a practitioner at certain hospitals, clinics, and other health facilities licensed by the department of public health and environment; Long term care facilities; Assisted living residences; Home care agencies; The program of all-inclusive care for the elderly or PACE program; Adult day care facilities; or The compounding of drugs for animal use.(Note: Italicized words indicate new material added to the original summary; dashes through words indicate deletions from the original summary.)(Note: This summary applies to the reengrossed version of this bill as introduced in the second house.)
Sponsors (3)
- J. Carson Republican · sponsor
- I. Jodeh Democratic · sponsor
- J. Jackson Democratic · sponsor
Action history (22)
- May 5, 2026 House Committee on Health & Human Services Postpone Indefinitely · lower
- Apr 20, 2026 Introduced In House - Assigned to Health & Human Services · lower
- Apr 17, 2026 Senate Third Reading Passed with Amendments - Floor · upper
- Apr 10, 2026 Senate Third Reading Laid Over to 04/17/2026 - No Amendments · upper
- Apr 9, 2026 Senate Third Reading Laid Over to 04/10/2026 - No Amendments · upper
- Apr 8, 2026 Senate Third Reading Laid Over to 04/09/2026 - No Amendments · upper
- Apr 7, 2026 Senate Third Reading Laid Over to 04/08/2026 - No Amendments · upper
- Apr 6, 2026 Senate Third Reading Laid Over to 04/07/2026 - No Amendments · upper
- Mar 30, 2026 Senate Third Reading Laid Over to 04/06/2026 - No Amendments · upper
- Mar 27, 2026 Senate Third Reading Laid Over to 03/30/2026 - No Amendments · upper
- Mar 26, 2026 Senate Third Reading Laid Over to 03/27/2026 - No Amendments · upper
- Mar 25, 2026 Senate Third Reading Laid Over to 03/26/2026 - No Amendments · upper
- Mar 24, 2026 Senate Third Reading Laid Over to 03/25/2026 - No Amendments · upper
- Mar 23, 2026 Senate Third Reading Laid Over to 03/24/2026 - No Amendments · upper
- Mar 20, 2026 Senate Third Reading Laid Over to 03/23/2026 - No Amendments · upper
- Mar 19, 2026 Senate Third Reading Laid Over to 03/20/2026 - No Amendments · upper
- Mar 18, 2026 Senate Third Reading Laid Over to 03/19/2026 - No Amendments · upper
- Mar 17, 2026 Senate Third Reading Laid Over to 03/18/2026 - No Amendments · upper
- Mar 16, 2026 Senate Second Reading Passed with Amendments - Committee, Floor · upper
- Mar 10, 2026 Senate Second Reading Laid Over to 03/16/2026 - No Amendments · upper
- Mar 5, 2026 Senate Committee on Health & Human Services Refer Amended to Senate Committee of the Whole · upper
- Jan 28, 2026 Introduced In Senate - Assigned to Health & Human Services · upper
Full text
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